US2012252831A1PendingUtilityA1

Compositions of opioid antagonists and methods for treating scleroderma therewith

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Assignee: PISAK IBRAHIM MUSTAFA ISKENDERPriority: Mar 31, 2011Filed: Mar 31, 2011Published: Oct 4, 2012
Est. expiryMar 31, 2031(~4.7 yrs left)· nominal 20-yr term from priority
Inventors:Ibrahim Mustafa Iskender PisakSemra BingolMehmet Levent SelamogluMehmet Nevzat Pisak
A61K 9/0019A61K 31/485A61K 9/06A61K 47/20A61P 19/00A61K 9/10A61K 47/10A61K 9/4866A61K 47/14A61K 47/06
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Claims

Abstract

Provided are compositions comprising opioid antagonists, such as naltrexone naloxone, or nalmefene, or their pharmaceutically acceptable salts, and methods for treating scleroderma, including systemic sclerosis, therewith.

Claims

exact text as granted — not AI-modified
1 . A method for treating scleroderma comprising administering to a subject in need thereof an effective amount of an opioid antagonist or a pharmaceutically acceptable salt thereof. 
     
     
         2 . The method of  claim 1 , wherein the opioid antagonist is naltrexone, naloxone, nalorphine, levallorphan, nalmefene, cyprodime, naltindole, or norbinaltorphimine. 
     
     
         3 . The method of  claim 1 , wherein the opioid antagonist is naloxone. 
     
     
         4 . The method of  claim 1 , wherein the opioid antagonist is nalmefene. 
     
     
         5 . The method of  claim 1 , wherein the opioid antagonist is naltrexone. 
     
     
         6 . The method of  claim 5 , wherein the naltrexone has less than about 10% by weight of other steroisomers. 
     
     
         7 . The method of  claim 5 , wherein the naltrexone has less than about 5% by weight of other steroisomers. 
     
     
         8 . The method of  claim 1 , wherein the scleroderma is systemic sclerosis. 
     
     
         9 . The method of  claim 1 , wherein the opioid antagonist is administered in the form of a composition comprising the opioid antagonist and at least one pharmaceutically acceptable excipient. 
     
     
         10 . The method of  claim 9 , wherein the composition is formulated for topical administration. 
     
     
         11 . The method of  claim 10 , wherein the opioid antagonist is present in an amount of about 0.1% to about 5% by weight of the composition. 
     
     
         12 . The method of  claim 10 , wherein the opioid antagonist is present in an amount of about 0.5% to about 2% by weight of the composition. 
     
     
         13 . The method of  claim 10 , wherein the opioid antagonist is present in an amount of about 1% by weight of the composition. 
     
     
         14 . The method of  claim 10 , wherein the composition is in the form of a gel, cream, ointment, liquid, suspension, solution, emulsion, foam, or aerosol. 
     
     
         15 . The method of  claim 10 , wherein the composition is administered to the subject by spreading or spraying the composition onto the affected area. 
     
     
         16 . The method of  claim 10 , wherein the opioid antagonist is administered in a total daily dose of up to about 150 mg/cm 2  of skin. 
     
     
         17 . The method of  claim 10 , wherein the opioid antagonist is administered in a total daily dose of about 10 mg/cm 2  to about 100 mg/cm 2  of skin. 
     
     
         18 . The method of  claim 10 , wherein the opioid antagonist is administered in a total daily dose of about 50 mg/cm 2  of skin. 
     
     
         19 . The method of  claim 9 , wherein the composition is formulated for oral administration. 
     
     
         20 . The method of  claim 19 , wherein the formulation is in the form of a tablet or capsule. 
     
     
         21 . The method of  claim 19 , wherein the opioid antagonist is present in an amount of about 0.1 mg to about 10 mg. 
     
     
         22 . The method of  claim 19 , wherein the opioid antagonist is present in an amount of about 1 mg to about 4.5 mg. 
     
     
         23 . The method of  claim 19 , wherein the opioid antagonist is present in an amount of about 2 mg. 
     
     
         24 . The method of  claim 1 , wherein the opioid antagonist is administered 1, 2, 3, 4, or 5 times daily. 
     
     
         25 . The method of  claim 1 , further comprising administering to the subject one or more additional agents effective to treat the scleroderma. 
     
     
         26 . A kit comprising a unit dose of an opioid antagonist and a label or printed instructions instructing the administration of the opioid antagonist to treat scleroderma. 
     
     
         27 . The kit of  claim 26 , wherein the scleroderma is systemic sclerosis. 
     
     
         28 . The kit of  claim 26 , wherein the administration is topical administration.

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